Table A4: Summary of Study Methodological Characteristics that Impact Study Quality*.
Study | N | Adequate Randomization Methods | Adequate Allocation Concealment | Blinding | Power | Loss to FUP | Intention-to-Treat |
---|---|---|---|---|---|---|---|
Cotton et al, 2000 (21) | 81 | ✓ (random numbers) | ✓ | NR | No a priori sample size calculation Underpowered based on post hoc sample size calculations |
✓ | Methods say ITT but does not account for withdrawals |
Davies et al, 2000 (20) | 150 | Methods not reported | Unclear (opaque envelopes not specified) | NR | A priori sample size calculation Underpowered based on post hoc sample size calculations |
✓ | Methods say ITT but does not account for withdrawals |
Ojoo et al, 2000 (22) | 60 | Methods not reported | Unclear (opaque envelopes not specified) | NR | No a priori sample size calculation Underpowered based on post hoc sample size calculations |
20% | NR |
Aimonino Ricauda et al, 2008 (19) | 104 | ✓ (random numbers) | ✓ | ✓ (outcome assessment blinded) | A priori sample size calculation Adequate power for readmissions Underpowered for mortality and other outcomes based on post hoc sample size calculations |
✓ | Methods say ITT but does not account for withdrawals |
Shepperd et al, 1998, (15;18) | 32† | ✓ (computer-generated random numbers) | ✓ | NR | A priori sample size calculation (HRQOL outcome) Underpowered based on post hoc sample size calculations |
NR | Methods say ITT but not clear if analysis accounts for withdrawals |
Skwarska et al, 2000 (6) | 184 | ✓ (computer-generated random numbers) | NR | NR | No a priori sample size calculation Underpowered based on post hoc sample size calculations |
30% | NR |